MAUDE Adverse Event Report: CLASSIC WIRE CUT CO, INC. CONCEPT GRAFIX TENDON STRIPPER, 7.0MM; LXH - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number TS8850

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

The distributor reported on behalf of the customer that the device, ts8850 concept grafix tendon stripper, 7.0mm was being used on 23jun22 during an anterior cruciate ligament reconstruction and ¿a tendon stripper lot: 37946 is broken at the tip during acl case as per attached image.Luckily the tip did not fall inside the patient¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed without an alternate device and there was a 2 hour delay.After further assessment it was found that the tendon stripper was being used just as "usual usage" when the event occurred.The tip broke off when it was about to cut at the end of the tendon.The patients current condition is "no problem".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Visual examination of the returned used device, item ts8850 found device bent at the tip and broken off.Broken tip was returned for evaluation.Evaluation was performed per print ts8850.Suspect, excessive force used during the case.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A review of the device history record was requested by the supplier but has not been received to date.A two-year review of complaint history revealed there has been a total of 5 reports, regarding 5 devices, for this device family and failure mode.During this same time frame 286 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.02.Per the instructions for use, the user is advised the following: inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Inspect instrument after use to ensure it has not been damaged.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the device, ts8850 concept grafix tendon stripper, 7.0mm was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction and ¿a tendon stripper lot: 37946 is broken at the tip during acl case as per attached image.Luckily the tip did not fall inside the patient¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed without an alternate device and there was a 2 hour delay.After further assessment it was found that the tendon stripper was being used just as "usual usage" when the event occurred.The tip broke off when it was about to cut at the end of the tendon.The patients current condition is "no problem".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CONCEPT GRAFIX TENDON STRIPPER, 7.0MM
• Type of Device: LXH - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15087959
• MDR Text Key: 304803514
• Report Number: 1017294-2022-00083
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TS8850
• Device Lot Number: 37946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic